Disetronic Pen P100
by Disetronic Medical Systems 510(k)
Active
510(k) K993666
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993666 | Date22 Nov 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Disetronic Pen P100 is a syringe, piston-type device designed for the injection of insulin. It is classified under product code FMF as a Class II medical device, intended for use in general hospital settings. This pen-style injector incorporates a pre-filled or attachable cartridge system to deliver precise insulin doses, facilitating patient self-administration or clinical use.
Supplied as a single-use device, the Disetronic Pen P100 requires no sterilisation beyond manufacturer packaging. It is regulated under FDA 510(k) clearance (K993666) via the Special pathway, with a decision date of November 22, 1999. The device is non-magnetic and MRI-safe, though storage conditions should adhere to manufacturer guidelines for insulin cartridges. No additional regulatory markings beyond the FDA clearance are specified.
Other devices from Disetronic Medical Systems
Questions
AI-generated answers, 1 Oct 2026
What is the Disetronic Pen P100 used for?
The Disetronic Pen P100 is a syringe-style injector designed specifically for the administration of insulin. It uses a piston mechanism to deliver precise doses, making it suitable for both patient self-injection and clinical settings. The pen-style format simplifies dosing accuracy, which is critical for managing diabetes effectively.
Is the Disetronic Pen P100 single-use or reusable?
The Disetronic Pen P100 is a single-use device. This design ensures sterility and safety, as it requires no additional sterilization beyond the manufacturer’s sealed packaging. After use, it should be discarded to prevent contamination or cross-infection.
How is the Disetronic Pen P100 supplied, and what cartridges can be used?
The Pen P100 is supplied as a standalone injector that can accommodate pre-filled insulin cartridges or attachable cartridges. The device is compatible with insulin cartridges that adhere to standard pen-style injector specifications. Always verify cartridge compatibility with the manufacturer’s guidelines to ensure proper function and dosing.
Can the Disetronic Pen P100 be used in an MRI environment?
Yes, the Disetronic Pen P100 is non-magnetic and MRI-safe. However, storage conditions for insulin cartridges should follow the manufacturer’s recommendations to maintain efficacy. Always confirm with the device documentation or manufacturer if specific storage requirements apply to your insulin type.
What regulatory clearance does the Disetronic Pen P100 hold?
The Disetronic Pen P100 holds FDA 510(k) clearance under the Special pathway, classified under product code FMF for general hospital use. The clearance number is K993666, with a decision date of November 22, 1999. This classification confirms its equivalence to a predicate device and compliance with U.S. regulatory standards for insulin delivery systems.